by Amy Davis, JD, MPH, Senior Director for Programs and Publications at PRIM&R

Remember the Johns Hopkins-Michigan study in which the Michigan Hospital system implemented an intensive care unit-based check-list system for inserting a catheter to reduce central line infections? The project was submitted to the Johns Hopkins Medical Institution’s (JHMI) institutional review board (IRB) in 2004, who categorized the project as “exempt” from the federal regulations at 45 CFR 46 because data provided to Johns Hopkins researchers was de-identified and the project posed minimal risk.

Based on this determination, the project leaders did not ensure that the hospitals in which the study was conducted were federally approved to conduct “research” with “human subjects.” Neither did they obtain individual, written informed consent from the patients who were part of the pilot program. In 2006, OHRP received a complaint that the project violated federal regulations, and the rest is history.

The John Hopkins-Michigan study highlights the difficulty of determining the line between research and practice, or in this case, between research and quality improvement. The case is neither unique nor new. This issue was discussed prominently in the 1979 Belmont Report and over the years, examples that do not fall tidily within the definition of “human subjects research” have raised ethical questions about ethical oversight: activities that occur in the practice of public health, quality improvement, clinical innovation, and community-based health initiatives, to name a few.

The fact is that sometimes people carry out activities that resemble both ordinary practice and the development of generalizable knowledge, a central characteristic of research. These individuals, and the human subjects office at their institutions, then find themselves wondering “does this activity require IRB review?” Such longstanding ambiguity and confusion leads to wasted resources at a minimum, and exposure to undue risk at worst. It is time to provide more guidance to institutions, practitioners, and IRBs about how to manage the ethical issues that lie at the border of research and practice.

This is the goal of PRIM&R’s project titled “The Boundaries Between Research and Practice.” This initiative was launched last year when PRIM&R hosted a meeting on the topic facilitated by PRIM&R board members, Alex Capron, LLB, Scott H. Bice Chair in Healthcare Law, Policy, and Ethics in the Gould School of Law at the University of Southern California; and Hugh Tilson, MD, MPH, DrPH, Adjunct Professor and Senior Advisor at the University of North Carolina at Chapel Hill School of Public Health. That meeting led to a follow-up gathering in National Harbor, MD during the 2011 Advancing Ethical Research Conference, titled Town Hall Meeting: “Bumping Into Things: What are the Boundaries of Research and Why Might We Want to Know?”

During this dynamic event, the moderators and participants discussed examples of borderline situations from different areas of practice, and discussed the salient characteristics that define them as either “like” or “unlike” research. Characteristics such as level of risk, extent of deviation from common practice, nature of potential benefit, and extent of systemization have emerged from the discussions to date. Participants also discussed alternative review mechanisms that they have used for non-research activities that raise ethical concerns. Review systems such as ethics audits, human subjects office staff review, and consultations with ethicists were described.

The participants were gratified to learn how their peers were handling borderline cases, but they confirmed the need for effective guidelines that advance ethical conduct and encourage creativity and action. The more information that we receive about these experiences, the better informed we will be to develop useful guidelines. So we are coming to you to ask for your input. Please contribute your expertise, your questions, and/or your experiences with managing cases at the “border.” Here are some questions to prompt your thinking.

• As a practitioner, have you struggled with the question of whether your IRB should review a project before its implementation?
• As an IRB member, have you heard about a project that was not submitted for IRB approval that you thought should have been? Or have you been asked to review a project proposal that you felt was outside the IRB’s jurisdiction, but that raised ethical questions requiring oversight?
• As an administrator, have you established or employed alternative systems for review?
• What project characteristics do you believe should determine whether an activity requires ethical oversight and what kind of entity would you recommend for this purpose?

Please share your thoughts here.